FDA Device recall Z-2782-2020
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and…
- FDA Device
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and… by Flower Orthopedics, citing the contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2782-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-08 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flower Orthopedics |
| Distribution | US |
Product
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Reason
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Identifiers
| code_info | Lot Number 1909660028; UDI 00840118115643 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2782-2020%22
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